HNSCCST-ICI02NCT04892849
Clinical Benefit and Biomarker Analysis of Combination of PD-1/PD-L1 Immune Checkpoint Inhibitors and Radiotherapy
An observational study of HNSCC and NSCLC, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
Inhibitors of the programmed cell death protein 1 (PD-1)/PD-L1 immune checkpoint signaling pathway are already approved in the treatment of various tumor entities in relapsed or metastatic stages. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HNSCC, NSCLC, Esophageal Cancer
- What is being tested?
- Conventional Therapy acc. to prevailing clincal approved schemes
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 30 Apr 2021to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study cohort consist of patients suffering from HNSCC (palliative), NSCLC (separately palliative and adjuvant) and "other solid tumors" (including in particular esophageal carcinomas, urothelial and renal carcinomas, small cell bronchial carcinomas and squamous cell carcinomas of the skin [depending on the current drug approval]) which will be treated with ICI (PD-1/PD-L1) and potential radiation of metastases at Department of Radiation Oncology of Universitätsklinikum Erlangen.
Who may be able to join
- Patients treatable for HNSCC (palliative), NSCLC (separately palliative and adjuvant) or "other solid tumour"
- Indication for system therapy with a PD-1/PD-L1 inhibitor according to clinical standards
- Patients without or with radiation of one or more metastases
- Age at least 18 years
Who cannot join
- Melanoma patients
- Fertile patients who refuse effective contraception during study treatment
- Persistent drug and/or alcohol abuse
- Patients not able or willing to behave according to study protocol
- Patients in care
- Patients that are not able to speak German
- Patients which are imprisoned according to legal or governmental order
- Both gender are included into the study, a maximum age was not defined.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Radiation Oncology, Universitätsklinikum Erlangen
Erlangen, Bavaria, 91054
Benjamin Frey, Dr.-Ing., +49 9131 85 ext. 44248, benjamin.frey@uk-erlangen.de
Anna Donaubauer, M.Sc., +49 9131 85 ext. 32311, anna-jasmina.donaubauer@uk-erlangen.de
About this study
Official title: Clinical Benefit and Biomarker Analysis of Combination of PD-1/PD-L1 Immune Checkpoint Inhibitors and Radiotherapy in NSCLC, HNSCC and Other Solid Tumors
Inhibitors of the programmed cell death protein 1 (PD-1)/PD-L1 immune checkpoint signaling pathway are already approved in the treatment of various tumor entities in relapsed or metastatic stages. Different exploratory trials suggest that the combination of radiotherapy and PD-1/PD-L1 inhibitors is highly effective, especially in oligometastatic stages and if all lesions are treated with ablative radiotherapy. In addition, the role of predictive biomarkers is becoming increasingly important for future therapy algorithms. First data, also from our group, indicate clearly that dynamic changes of immune cells and their activation markers in the peripheral blood (immune matrix) can be used as predictive biomarkers. During the planned STICI-02 trial predictive immune matrix derived from the STICI01 trial (NCT03453892) will be validated in the groups of patient suffering from HNSCC (palliative), NSCLC (separately palliative and adjuvant) and "other solid tumors" (including in particular esophageal carcinomas, urothelial and renal carcinomas, small cell bronchial carcinomas and squamous cell carcinomas of the skin [depending on the current drug approval]). Within the framework of scientific accompanying projects, the predictive value of markers in tumor tissue and of pattern radiomics analyses will be analyzed accompanying the immunophenotyping in peripheral blood. The side effects
- Conditions
- HNSCC, NSCLC, Esophageal Cancer, Urothelial Carcinoma, Renal Cell Carcinoma, Squamous Cell Carcinoma of the Skin
- Being tested
- Conventional Therapy acc. to prevailing clincal approved schemes
- Keywords
- Immunotherapy, Radiotherapy
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Esophageal Neoplasms, Carcinoma, Transitional Cell, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Therapy acc. to prevailing clincal approved schemesOther
The study is observational. The treatment-plan of the underlying disease remains unchanged. The treatment of the patient is according to the prevailing clinical approved schemes at the respective entities. Blood will be drawn from patients at several time points during and after RT and ICI for detailed immunomonitoring of the patients.
| Study group | Role | What they receive |
|---|---|---|
| Trial cohort | The study cohort consist of patients suffering from HNSCC (palliative), NSCLC (separately palliative and adjuvant) and "other solid tumors" (including in particular esophageal carcinomas, urothelial and renal carcinomas, small cell bronchial carcinomas and squamous cell carcinomas of the skin [depending on the current drug approval]) which will be treated with ICI (PD-1/PD-L1) and potential radiation of metastases at Department of Radiation Oncology of Universitätsklinikum Erlangen. Receives: Other: Conventional Therapy acc. to prevailing clincal approved schemes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overallsurvival
Prospective investigation of the survival of the patients.
Measured: From inclusion till death of subject or up to 5 years, whichever came first.
Longitudinal Immunophenotype
Longitudonal Immunophenotyping of the patients: Detection of about 30 distinct immune cell (sub)types together with their activation markers during treatement.
Measured: Day 0 till progression or end of study up to 5 years or till change to conventional treatment without ICI, whichever came first.
Predictors in pattern recognition analyses
Identification of possible predictors in pattern recognition analyses from clinical imaging data sets.
Measured: Day 0 till progression or end of study up to 5 years or till change to conventional treatment without ICI, whichever came first.
Immune-associated side effects
Detection of immune-associated side effects
Measured: Day 0 till progression or end of study up to 5 years or till change to conventional treatment without ICI, whichever came first.
Secondary outcomes (4)
Detection of adverse events according to NCI CTAE (v4.0)
The adverse effects of Immunecheckpoint and Radiotherapy is recorded by official questionaire
Measured: From date of inclusion to the trial until the date of first documented iRECIST progression or date of death from any cause, or till change to conventional treatment , whichever came first, assessed up to 5 years.
Progression free survival
survival of the patient without progression of malignant disesase
Measured: From date of inclusion to the trial until the date of first documented iRECIST progression or date of death from any cause, whichever came first, assessed up to 5 yeras
Treatment response (according to RECIST and iRECIST criteria)
RECIST and iRECIST criteria will used to analyse the response of the patient to the respective treatement
Measured: From date of inclusion to the trial until the date of first documented iRECIST progression or date of death from any cause, whichever came first, assessed up to 5 years
Attempt to establish an immune matrix of responding/non-responding patients
Analysis of clincal, MRI and imunnologic, molecular data to develop an biomarkermatrix with processes of machine learning
Measured: The analyses are conducted at time points before (day 0) and before every prescription of ICI (every 14 to 21 days) till progression or end of study up to 5 years or till change to conventional treatment without ICI.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start30 Apr 2021
- Primary completion31 May 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HNSCCStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Markus Hecht, PD Dr., Study director, Universitätsklinikum Erlangen, Department of Radiation OncologyUdo S Gaipl, Prof. Dr., Principal investigator, Universitätsklinikum Erlangen, Department of Radiation OncologyRainer Fietkau, Prof. Dr., Study chair, Universitätsklinikum Erlangen, Department of Radiation OncologyBenjamin Frey, PD Dr. Dr., Principal investigator, Universitätsklinikum Erlangen, Department of Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04892849
- Sponsor's protocol ID
- ST-ICI02
- Acronym
- ST-ICI02
- Status last verified
- Sep 2025
- First submitted
- 26 Apr 2021
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Benefit and Biomarker Analysis of Combination of PD-1/PD-L1 Immune Checkpoint Inhibitors and Radiotherapy in NSCLC, HNSCC and Other Solid Tumors
- ClinicalTrials.gov ID
- NCT04892849
- Acronym / sponsor ID
- ST-ICI02 / ST-ICI02
- Conditions
- HNSCC, NSCLC, Esophageal Cancer, Urothelial Carcinoma, Renal Cell Carcinoma, Squamous Cell Carcinoma of the Skin
- Keywords
- Immunotherapy, Radiotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 19 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Inhibitors of the programmed cell death protein 1 (PD-1)/PD-L1 immune checkpoint signaling pathway are already approved in the treatment of various tumor entities in relapsed or metastatic stages. Different exploratory trials suggest that the combination of radiotherapy and PD-1/PD-L1 inhibitors is highly effective, especially in oligometastatic stages and if all lesions are treated with ablative radiotherapy. In addition, the role of predictive biomarkers is becoming increasingly important for future therapy algorithms. First data, also from our group, indicate clearly that dynamic changes of immune cells and their activation markers in the peripheral blood (immune matrix) can be used as predictive biomarkers. During the planned STICI-02 trial predictive immune matrix derived from the STICI01 trial (NCT03453892) will be validated in the groups of patient suffering from HNSCC (palliative), NSCLC (separately palliative and adjuvant) and "other solid tumors" (including in particular esophageal carcinomas, urothelial and renal carcinomas, small cell bronchial carcinomas and squamous cell carcinomas of the skin [depending on the current drug approval]). Within the framework of scientific accompanying projects, the predictive value of markers in tumor tissue and of pattern radiomics analyses will be analyzed accompanying the immunophenotyping in peripheral blood. The side effects
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trial cohort | – | Other: Conventional Therapy acc. to prevailing clincal approved schemesThe study cohort consist of patients suffering from HNSCC (palliative), NSCLC (separately palliative and adjuvant) and "other solid tumors" (including in particular esophageal carcinomas, urothelial and renal carcinomas, small cell bronchial carcinomas and squamous cell carcinomas of the skin [depending on the current drug approval]) which will be treated with ICI (PD-1/PD-L1) and potential radiation of metastases at Department of Radiation Oncology of Universitätsklinikum Erlangen. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study cohort consist of patients suffering from HNSCC (palliative), NSCLC (separately palliative and adjuvant) and "other solid tumors" (including in particular esophageal carcinomas, urothelial and renal carcinomas, small cell bronchial carcinomas and squamous cell carcinomas of the skin [depending on the current drug approval]) which will be treated with ICI (PD-1/PD-L1) and potential radiation of metastases at Department of Radiation Oncology of Universitätsklinikum Erlangen.
Key inclusion criteria (4 listed)
- Patients treatable for HNSCC (palliative), NSCLC (separately palliative and adjuvant) or "other solid tumour"
- Indication for system therapy with a PD-1/PD-L1 inhibitor according to clinical standards
- Patients without or with radiation of one or more metastases
- Age at least 18 years
Key exclusion criteria (8 listed)
- Melanoma patients
- Fertile patients who refuse effective contraception during study treatment
- Persistent drug and/or alcohol abuse
- Patients not able or willing to behave according to study protocol
- Patients in care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional Therapy acc. to prevailing clincal approved schemesThe study is observational. The treatment-plan of the underlying disease remains unchanged. The treatment of the patient is according to the prevailing clinical approved schemes at the respective entities. Blood will be drawn from patients at several time points during and after RT and ICI for detailed immunomonitoring of the patients. | Other | Trial cohort |
Primary outcome
Overallsurvival
Time frame: From inclusion till death of subject or up to 5 years, whichever came first.
Prospective investigation of the survival of the patients.
Longitudinal Immunophenotype
Time frame: Day 0 till progression or end of study up to 5 years or till change to conventional treatment without ICI, whichever came first.
Longitudonal Immunophenotyping of the patients: Detection of about 30 distinct immune cell (sub)types together with their activation markers during treatement.
Predictors in pattern recognition analyses
Time frame: Day 0 till progression or end of study up to 5 years or till change to conventional treatment without ICI, whichever came first.
Identification of possible predictors in pattern recognition analyses from clinical imaging data sets.
Immune-associated side effects
Time frame: Day 0 till progression or end of study up to 5 years or till change to conventional treatment without ICI, whichever came first.
Detection of immune-associated side effects
4 secondary outcomes
Detection of adverse events according to NCI CTAE (v4.0)
Time frame: From date of inclusion to the trial until the date of first documented iRECIST progression or date of death from any cause, or till change to conventional treatment , whichever came first, assessed up to 5 years.
Progression free survival
Time frame: From date of inclusion to the trial until the date of first documented iRECIST progression or date of death from any cause, whichever came first, assessed up to 5 yeras
Treatment response (according to RECIST and iRECIST criteria)
Time frame: From date of inclusion to the trial until the date of first documented iRECIST progression or date of death from any cause, whichever came first, assessed up to 5 years
Attempt to establish an immune matrix of responding/non-responding patients
Time frame: The analyses are conducted at time points before (day 0) and before every prescription of ICI (every 14 to 21 days) till progression or end of study up to 5 years or till change to conventional treatment without ICI.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Individual participant dataSharing planned: Undecided
Related trials for HNSCC
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2
Proton Spatially Fractionated Radiotherapy or Photon Stereotactic Body Radiotherapy in Combination With Pembrolizumab Before Surgery for the Treatment of Locally Advanced and Radiation-Naive Locoregionally Recurrent Oral Cavity Cancer, OSPRI Trial
Locally Advanced Oral Cavity Squamous Cell Carcinoma, Locally Recurrent Oral Cavity Squamous Cell Carcinoma
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
Head and Neck Cancer, Head and Neck Squamous Cell Cancer
RecruitingPhase 3
Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment
Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hypopharyngeal Squamous Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Markus Hecht, PD Dr. study director
Universitätsklinikum Erlangen, Department of Radiation Oncology
Udo S Gaipl, Prof. Dr. principal investigator
Universitätsklinikum Erlangen, Department of Radiation Oncology
Rainer Fietkau, Prof. Dr. study chair
Universitätsklinikum Erlangen, Department of Radiation Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HNSCC and NSCLC, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Markus Hecht, PD Dr. (+49 9131 85 ext. 44247, markus.hecht@uk-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overallsurvival (time frame: From inclusion till death of subject or up to 5 years, whichever came first.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.